Summary of Product Characteristics
last updated on the eMC:
27/04/2011
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 27/04/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.6 - Pregnancy and Lactation
|
| Date of revision of text on the SPC: 01-Apr-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Update to 4.4/4.6 relating to codeine and breast-feeding
|
|
Updated on 28/06/2010 and displayed until 27/04/2011
|
Reasons for adding or updating:
|
-
Change to section 4.1 - Therapeutic indications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 6. 5 - Nature and Contents of Container
|
| Date of revision of text on the SPC: 01-Sep-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| changes made to sections 4.1 and 4.4 to add additional codeine warnings and to section 6.5 to remove packs containing more than 32 tablets.
|
|
Updated on 22/12/2006 and displayed until 28/06/2010
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
|
| Date of revision of text on the SPC: 12/2005 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.4 To update SPC and product labelling with respect to codeine as requested by the MHRA.
|
|
Updated on 17/08/2005 and displayed until 22/12/2006
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 15/08/2005 and displayed until 17/08/2005
|
Reasons for adding or updating:
|
-
Change to section 6. 5 - Nature and Contents of Container
|
|
Updated on 23/12/2004 and displayed until 15/08/2005
|
Reasons for adding or updating:
|
-
Change to section 4.9 - Overdose
|
|
Updated on 16/11/2001 and displayed until 23/12/2004
|
Reasons for adding or updating:
|
|
|
|